This invention relates to a deformable intraocular lens insertion system including a lens injecting device and a lens cartridge that can be connected and locked together after loading the deformable intraocular lens into the lens cartridge. Further, the present invention relates to a deformable intraocular lens insertion system having one or more disposable components, in particular a deformable intraocular lens insertion system comprising two separate main components including a disposable lens injecting device and a disposable lens cartridge.
The deformable intraocular lens insertion system currently being sold and marketed by STAAR Surgical Company of California has gain widespread acceptance in the field of deformable intraocular lens implantation. The current system utilizes an injector made of titanium so that the unit can be autoclaved and reused numerous times. The components of the titanium injector are machined from bar stock to a high degree of accuracy according to current specifications, and then the components are assembled into the final injector unit. The cost of the materials, and labor costs involve with machining and assembly are substantial providing an incentive to seek less expensive alternatives. Further, the steps of cleaning and autoclaving the injector unit between operations is a time burden and nuisance to busy surgeon practitioners having back-to-back operation schedules. In addition, the injector must be properly autoclaved to ensure complete cleaning and sterilization to prevent spread of diseases causing eye infections or other infectious diseases, prevent transmission of body fluid and prevent resulting liability problems to surgeon practitioners. These and other considerations have led to the development of the present invention.
An object of the present invention is to provide an improved deformable intraocular lens insertion system.
A second object of the present invention is to provide a deformable intraocular lens insertion system comprising a lens injecting device and lens cartridge that can be connected and locked together.
A third object of the present invention is to provide a deformable intraocular lens insertion system including a lens injecting device and lens cartridge that can be connected together by a rotary connection therebetween.
A fourth object of the present invention is to provide a deformable intraocular lens insertion system comprising a lens injecting device and lens cartridge that can be connected and locked together by a rotary connection therebetween.
A fifth object of the present invention is to provide a deformable intraocular lens insertion system comprising one or more disposable components.
A sixth object of the present invention is to provide a fully disposable deformable intraocular lens insertion system comprising a disposable lens injecting device and a disposable lens cartridge.
A seventh object of the present invention is to provide a disposable lens injecting device for a deformable intraocular lens insertion system.
An eighth object of the present invention is to provide a disposable lens cartridge for a deformable intraocular lens insertion system.
A ninth object of the present invention is to provide a disposable lens cartridge having a downwardly tapering passageway for further folding the deformable intraocular lens as it moves through the lens cartridge.
A tenth object of the present invention is to provide a lens cartridge preloaded with a deformable intraocular lens.
An eleventh object of the present invention is to provide a deformable intraocular lens insertion system comprising a lens injecting device and a lens cartridge that can be connected and locked together by a bayonet-type connection therebetween.
A twelfth object of the present invention is to provide a deformable intraocular lens insertion system comprising a lens injecting device with a slot for accommodating a protrusion of the lens cartridge wherein the slot is configured to connect and lock the lens cartridge and a lens injecting device together.
A thirteenth object of the present invention is to provide a deformable intraocular lens insertion system comprising a lens injecting device with a longitudinal slot leading to a transverse slot for accommodating a protrusion of the lens cartridge for connecting and locking the lens cartridge and lens injecting device together.
A fourteenth object of the present invention is to provide a deformable intraocular lens insertion system having a pre-loaded deformable intraocular lens for storage and shipment.
A fifteenth object of the present invention is to provide an intraocular lens insertion system comprising a lens injecting device and lens cartridge with the deformable intraocular lens pre-loaded in the lens cartridge for storage and shipment.
These and other objects can be achieved by various embodiments of the present invention. Specifically, the present invention is directed to the main features of:
1) a rotary connection between the lens cartridge and the lens injecting device for connecting the lens cartridge to the lens injecting device;
2) a rotary connection between the lens cartridge and the lens injecting device for releasably connecting the lens cartridge to the lens injecting device to allow these components to be assembled and disassembled;
3) a rotary connection between the lens cartridge and the lens injecting device for permanently connecting the lens cartridge to the lens injecting device to prevent these components from being disassembled once assembled;
4) a rotary connection between the lens cartridge and the lens injecting device to both releasably connect and releasably lock the lens cartridge to the lens injecting device to allow these components to be assembled and disassembled, however, positively locking these components together to prevent inadvertent disassembly;
5) one or more components of the deformable intraocular lens insertion system are disposable. Preferably, the entire system excluding the deformable intraocular lens itself is disposable to provide the full advantages according to the present invention;
6) preloading the deformable intraocular lens insertion system with a deformable intraocular lens; and
7) preloading the lens cartridge with the deformable intraocular lens.
The rotary connection feature allows for quick and secure connection between the lens cartridge and the lens injecting device. It is important that when the lens cartridge is connected to the lens injecting device that there is no relative movement between the lens cartridge and lens injecting device, especially in the longitudinal and transverse directions of the lens injecting device to maintain the handling features of the apparatus during the surgical procedure. Any disassembly or looseness between the lens cartridge and lens injecting device can cause misalignment of the plunger tip with the deformable intraocular lens causing lens damage, or worse could cause potential damage to the eye.
The rotary connection can be provided by a large variety of designs that involve threads, locking tabs, interference fit or snap fit connection, and many other types of rotary mechanical connections. A preferred embodiment utilize a bayonet-type connection, which involves relative longitudinal movement followed by transverse movement between the lens cartridge and lens injecting device. One type of bayonet-type connection can be achieve by providing one end of the lens injecting device with a longitudinal slot leading to a transverse slot for cooperating with a tab or protrusion on the lens cartridge.
A preferred embodiment of the slot-type connection includes providing the transverse slot with means for positively gripping or locking the tab of the lens cartridge. For example, locking tabs, interference fit connection, snap fit connection can be provided between structure located at, in or adjacent to the transverse slot and the tab of the lens cartridge. A preferred embodiment is provided with a transverse slot having a first transverse slot portion dimensioned in width slightly less than the width of the tab of the lens holder providing some interference and resistance when the tab of the lens cartridge is rotated through the first transverse slot portion. The first transverse slot portion extends to a second transverse slot portion dimensioned in width slightly wider that the width of the first transverse slot portion. This arrangement provides a pair of opposed locking tabs in the transverse slot so that when the tab of the lens cartridge is rotated to the fully locked position, the tab snap fits into the second transverse slot portion preventing inadvertent disassembly of the lens cartridge from the lens injecting device. Specifically, the trailing edges of the tab of the lens holder become locked due to interference with the locking tabs in the transverse slot.
This arrangement can be designed to permanently connect the lens cartridge to the lens injecting device by designing the snap fit connection to engage so as to essentially permanently connect the components in such a manner that disassembly can only be obtained by destruction or damage to one or more of the components. However, this arrangement is particularly suitable to allow the components to be separated or damaged by designing the snap fit connect to engage in such a manner that allows disassembly when a certain level of force is applied without any significant damage or wear to the components.
The components of the deformable intraocular lens insertion system according to the present invention must withstand sterilization methods, in particular autoclaving, in order to be practically utilized. Preferably, the components of the intraocular lens insertion system according to the present invention are made from plastic, most preferably autoclavable plastic (i.e. plastic having a melting point above approximately 121 degree Celsius) such as polysulfone, polycarbonate, nylon-66, TEFLON and KYNAR that can withstand the conditions of high temperature and pressure inside conventional autoclaving units. Further, the use of plastic allows the components of the deformable intraocular insertion system to be injection molded and quickly assembled significantly reducing cost in the construction thereof verses a titanium or stainless steel injector.
An embodiment of the disposable insertion system comprises two separate main components including a lens injecting device and a lens cartridge. The lens injecting device includes a barrel with a lens cartridge receiver for accommodating the lens cartridge, which accommodates a folded deformable intraocular lens. The lens injecting device preferably includes a cylindrical barrel having the lens cartridge receiver positioned at one end, and a movable plunger accessible at an opposite end. Specifically, the end fitted with the movable plunger is provided with a guide for defining a passageway for accommodating the movable plunger. The guide is preferably molded as part of the inside of the cylindrical barrel, however, alternatively can be made as a separate piece and then assembled in some suitable manner inside the cylindrical barrel.
The guide preferably is configured to allow sliding movement of the movable plunger in a longitudinal direction with relation to the cylindrical barrel, however, not allowing rotational movement of the movable plunger with respect to the cylindrical barrel. For example, the guide is provided with a keyway preventing relative rotation. In one preferred embodiment, the passageway through the guide has a passageway with a cross-sectional shape matching a movable plunger preventing relative rotation.
The lens cartridge receiver located at on end of the cylindrical barrel in preferably a cylindrical shaped receiver for accommodating the lens cartridge containing the deformable intraocular lens. Further, the cylindrical barrel is provided with means for defining the rotary connection for connecting and securely retaining the lens cartridge inside the front open end of the cylindrical barrel. In addition to the rotary connection, an interference type connection can be provided between the open front end of the cylindrical barrel and the lens cartridge so that these components are securely connected together when inserting the lens cartridge into the open end of the cylindrical barrel. The interference connection can be provided by sizing a portion of or the entire outer dimension of the lens cartridge slightly greater than the inner dimension of the open end of the lens cartridge receiver. Further, one or both components can have tapering outer surfaces or locking tabs that interfere with each other to provide an interference or snap fit type connection.
One end of the plunger is provided with a manipulating tip for making contact with the deformable intraocular lens, forcing the deformable intraocular lens from the lens cartridge, and manipulating the deformable intraocular lens inside the eye. An opposite end of the plunger is provided with means for actuating the plunger. The opposite end can be provided with a freely rotating finger tip gripping device to allow a user to exert sufficient pressure on the end of the plunger to controllably force the deformable intraocular lens from the lens cartridge. For example, the finger tip gripping device is provided with a fluted exterior surface to facilitate gripping thereof, and a through hole having a predetermined size. The end of the plunger component is provided with an extension. having a cylindrical tab end that can be forced into and through the through hole in the finger tip gripping device providing a snap connection between these components, and also allowing free rotation between these components.
The manipulating end is faceted in a particular manner to prevent damage to the deformable intraocular lens, particularly the trailing haptic, during the step of forcibly pushing the deformable intraocular lens through the nozzle of the lens cartridge and into the eye.
The present invention includes the concept of pre-loading the deformable intraocular lens in the deformable insertion system. Specifically, a potentially preferred method of making and selling deformable intraocular lens is to pre-load the deformable intraocular lens in the lens injecting device for purposes of storage and shipping. For example, the deformable intraocular lens can be manufactured, and then placed inside the lens injecting device or lens cartridge (i.e. inside deformable intraocular lens insertion system) prior to being packaged and shipped to a customer. This method reduces the amount of packaging by not requiring separate packages for the deformable intraocular lens and the lens cartridge and/or lens injecting device. Further, the lens cartridge and/or lens injecting device protects the deformable intraocular lens during the process of packaging, shipping and other handling, and eliminates the step of loading the deformable intraocular lens into the lens cartridge and/or lens injecting device by the surgeon that could potentially cause damage thereto. Further, pre-loading the lens can eliminate misuse during surgery.
This method would allow the lens cartridge and/or lens injecting device and pre-loaded deformable intraocular lens to be autoclaved together prior to insertion of the deformable intraocular lens.